SuperNOVA Clinical Stenting Trial

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01292928
Recruitment Status : Completed
First Posted : February 10, 2011
Results First Posted : January 20, 2016
Last Update Posted : March 8, 2017
Information provided by (Responsible Party):
Boston Scientific Corporation

Brief Summary:
The primary objective of this clinical study is to determine whether the Innova Stent System shows acceptable performance in long-term (12-month) safety rates and vessel patency when treating femoropopliteal lesions.

Condition or disease Intervention/treatment Phase
Atherosclerosis of Native Arteries of the Extremities, Unspecified Device: Stent implantation Not Applicable

Detailed Description:

Atherosclerosis is a systemic disease that has become increasingly recognized in the expanding elderly population as a significant cause of morbidity and mortality. Atherosclerosis in the vessels of the lower extremities can cause a variety of symptoms ranging from intermittent claudication to ischemic rest pain and critical ischemia with major tissue loss. Typically, femoropopliteal lesions have been difficult to successfully treat with endovascular therapy because the disease is often diffuse and located in an area of the body subject to significant mobility stresses such as extension, contraction, compression, elongation, flexion and torsion.

The SuperNOVA clinical study is a prospective, single arm, controlled, multicenter, global study. Approximately 50 centers located in the United States, Europe, Canada and/or Australia are expected to participate in recruiting patients needing treatment of lesions in their femoropopliteal arteries. A maximum of 300 subjects will be enrolled to ensure that a minimum of 296 stented segments are treated with the Innova Stent System.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 299 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Stenting of the Superficial Femoral (SFA) and Proximal Popliteal Arteries (PPA) With the Boston Scientific INNOVA Self-Expanding Bare Metal Stent System
Study Start Date : April 2011
Actual Primary Completion Date : July 2014
Actual Study Completion Date : September 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Atherosclerosis

Arm Intervention/treatment
Experimental: Stent
Stent implantation into SFA/PPA
Device: Stent implantation
Stent implantation during the index procedure.

Primary Outcome Measures :
  1. Primary Safety Endpoint and Components [ Time Frame: 1 month for death, 12 months for target limb major amputation , and target lesion revascularization ]
    The safety endpoint assesses the occurrence of Major Adverse Events (MAEs) defined as all causes of death through 1 month, target limb major amputation through 12 months and/or target lesion revascularization through 12 months

  2. Co-Primary Efficacy Endpoints [ Time Frame: 12 months ]

    The co-primary efficacy endpoints assess vessel primary patency at 12 months post-procedure.

    • The co-primary efficacy analysis (1) will assess vessel primary patency in stented segments intended to be treated with core matrix stents (20 to 150 mm).
    • The co-primary efficacy analysis (2) will assess vessel primary patency in stented segments intended to be treated with the entire stent matrix (20 to 200 mm).

Secondary Outcome Measures :
  1. Secondary Safety Endpoint and Components [ Time Frame: 1 month ]
    The secondary safety endpoint assesses the occurrence of Major Adverse Events (MAEs) through 30 days. MAEs will include all causes of death, target limb major amputation and/or target lesion revascularization through 1 month

Other Outcome Measures:
  1. Technical and Procedural Success [ Time Frame: Up to 24 hours after the procedure ]
    • Technical success: ability to cross and dilate the lesion to achieve residual angiographic stenosis no greater than 30%
    • Procedural success: technical success with no MAEs within 24 hours of the procedure

  2. Primary Patency [ Time Frame: 12 months ]
    Primary patency is the percentage of lesions (target stented segments) that reach a time point without a hemodynamically significant stenosis assessed by Duplex Ultrasound (DUS) and without Target Lesion Revascularization (TLR) or bypass of the target lesion.

  3. Assisted Primary Patency [ Time Frame: 12 months ]
    Assisted primary patency is the percentage of lesions without TLR and those with TLR (not due to complete occlusion or bypass) that reach a time point without restenosis.

  4. Stent Fracture Rate [ Time Frame: 12 months ]

    Vascular InterVentional Advances (VIVA) definitions:

    Grade 0: No strut fractures

    Grade I: single strut fracture

    Grade II: multiple strut fractures

    Grade III: stent fracture(s) with preserved alignment of the components

    Grade IV: stent fracture(s) with mal-alignment of the components

    Grade V: stent fracture(s) in a trans-axial spiral configuration

  5. Rutherford Classification [ Time Frame: 12 months ]

    Class 0: Asymptomatic

    Class 1: Mild claudication

    Class 2: Moderate claudication

    Class 3: Severe claudication

    Class 4: Ischemic rest pain

    Class 5: Minor tissue loss - nonhealing ulcer, focal gangrene with diffuse pedal edema

    Class 6: Major tissue loss - extending above metatarsal (MT) level

    Rate of Primary Sustained Clinical Improvement: an improvement in Rutherford classification of one or more categories as compared to pre-procedure without the need for repeat TLR.

    Rate of Secondary Sustained Clinical Improvement: an improvement in Rutherford classification of one or more categories as compared to pre-procedure including those subjects with repeat TLR.

    Rate of Clinical Deterioration: downgrade in Rutherford classification of one or more categories as compared to pre-procedure

  6. Rate of Hemodynamic Improvement [ Time Frame: 12 months ]

    The Ankle-Brachial Index (ABI) is the ratio between the systolic pressure measured at the ankle and the systolic pressure measured in the arm.

    Hemodynamic Improvement: Increases in ABI of ≥ 0.10 or to an ABI ≥ 0.90 as compared to pre-procedure without the need for repeat TLR.

    Hemodynamic Improvement (Including TLR): Increases in ABI of ≥0.10 or to an ABI ≥0.90 as compared to pre-procedure including TLR.

  7. Walking Improvement Assessed by the Walking Impairment Questionnaire [ Time Frame: 12 months ]
    The Walking Impairment Questionnaire (WIQ) is a validated functional assessment questionnaire that evaluates walking ability with regard to speed, distance and stair climbing ability as well as the reasons that walking ability might be limited. Range of scores is between 0% and 100% with 100% being the best and 0% being the worst score.

  8. Walking Improvement (Time) Assessed by 6 Minute Hall Walk [ Time Frame: 12 months ]
    Assessment of walking improvement (time) by the administration of the 6 Minute Walk Test (6MWT). Participants were asked to walk for as long as they could; up to 6 minutes.

  9. Walking Improvement (Distance) Assessed by 6 Minute Hall Walk [ Time Frame: 12 months ]
    Assessment of walking improvement (distance) by the administration of the 6 Minute Walk Test (6MWT). Participants were asked to walk for as long as they could; up to 6 minutes.

  10. Quality of Life [ Time Frame: 12 months ]
    Improved Quality of Life assessed by the SF-36 Health Survey. The validated SF-36 Survey, where scores are calibrated so that 50 is the average score or norm, was utilized (scores ranging from 0, worst possible health to 100, best possible health). The SF-36 is a multipurpose, proprietary health survey with 36 questions that yield eight health component scales that can be further summarized into two summary scores: mental and physical health scores. The eight health component scales that can be computed from the questionnaire are physical function, role-physical, bodily pain, general health, vitality, role-emotional, mental health and social functioning.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Subjects age 18 and older
  2. Chronic symptomatic lower limb ischemia defined as Rutherford categories 2, 3 or 4
  3. Stenotic, restenotic (from angioplasty only) or occlusive lesion(s) located in the native superficial femoral artery or proximal popliteal artery:

    1. Degree of stenosis >/=70% by visual angiographic assessment
    2. Vessel diameter >/= 4 and </= 7mm
    3. Total lesion length (or series of lesions) >/=30mm and </= 190 mm (note: tandem lesions may be treated, provided that the tandem lesion segment can be covered with only one stent)
    4. If lesion is restenotic, PTA treatment must be >3 months prior to stent placement
    5. Target lesion located at least three centimeters above the inferior edge of the femur
  4. Patent infrapopliteal and popliteal artery, i.e., single vessel runoff or better with at least one of three vessels patent (<50% stenosis) to the ankle or foot
  5. Subject (or Legal Guardian) is willing and able to provide consent before any study-specific tests or procedures are performed and agrees to attend all required follow-up visits

Exclusion Criteria:

  1. Previous stent placement in the target vessel
  2. Subjects who have undergone prior surgery of the SFA/PPA in the target limb to treat atherosclerotic disease
  3. Subjects who have undergone prior percutaneous transluminal angioplasty (PTA) in the target SFA/PPA in the past 3 months
  4. Use of atherectomy devices or other adjunctive treatment in the SFA/PPA during the index procedure
  5. History of major amputation in the same limb as the target lesion
  6. Life expectancy less than 12 months due to other medical co-morbid condition(s) that could limit the subject's ability to participate in the clinical study, limit the subject's compliance with the follow-up requirements, or impact the scientific integrity of the clinical study
  7. Known hypersensitivity or contraindication to contrast dye that, in the opinion of the investigator, cannot be adequately pre-medicated.
  8. Intolerance to antiplatelet, anticoagulant, or thrombolytic medications
  9. Platelet count <150,000 mm3 or >600,000 mm3
  10. Concomitant renal failure with a serum creatinine >2.0 mg/dL
  11. Receiving dialysis or immunosuppressant therapy
  12. Pregnancy
  13. Current participation in another investigational drug or device clinical study
  14. Known allergy to Nitinol
  15. Septicemia at the time of the index procedure
  16. Presence of other hemodynamically significant outflow lesions requiring intervention within 30 days of the index procedure
  17. Target lesion is within or near an aneurysm
  18. Acute ischemia and/or acute thrombosis of the SFA/PPA
  19. Persistent, intraluminal thrombus of the proposed target lesion post- thrombolytic therapy
  20. Perforated vessel as evidenced by extravasation of contrast media
  21. Heavily calcified lesions

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01292928

  Hide Study Locations
United States, Alabama
Medical Center East
Birminham, Alabama, United States, 25235
United States, California
Cedars-Sinai Medical Center
Los Angeles, California, United States, 90048
United States, Georgia
St. Joseph's Hospital of Atlanta
Atlanta, Georgia, United States, 30342
United States, Illinois
Advocate Christ Medical Center
Oak Lawn, Illinois, United States, 60453
St. Francis Medical Center
Peoria, Illinois, United States, 61614
United States, Indiana
Parkview Hospital
Ft. Wayne, Indiana, United States, 46805
United States, Louisiana
Willis Knighton Bossier Medical Center
Bossier City, Louisiana, United States, 71111
Ochsner Clinic Foundation
New Orleans, Louisiana, United States, 70121
United States, Maryland
Frederick Memorial Hospital
Baltimore, Maryland, United States, 21287
United States, Massachusetts
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 05115
United States, Michigan
Northern Michigan Hospital
Petoskey, Michigan, United States, 49770
United States, Minnesota
Abbott Northwestern Hospital
Minneapolis, Minnesota, United States, 55407
United States, New Hampshire
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, United States, 03756
United States, New York
St. Joseph's Hospital Health Center
Liverpool, New York, United States, 13203
United States, North Carolina
Mid-Carolina Cardiology Presbyterian Hospital
Charlotte, North Carolina, United States, 28204
Rex Hospital
Raliegh, North Carolina, United States, 27607
Coastal Surgery Specialists
Wilmington, North Carolina, United States, 28401
United States, Ohio
Ohio State University Medical Center
Columbus, Ohio, United States, 43210
Grant Medical Center
Columbus, Ohio, United States, 43215
United States, Pennsylvania
UPMC - Passavant
Pittsburgh, Pennsylvania, United States, 15213
York Hospital
York, Pennsylvania, United States, 17405
United States, Tennessee
Methodist North Hospital
Memphis, Tennessee, United States, 35128
St. Thomas Research Institute, LLC
Nashville, Tennessee, United States, 37205
United States, Texas
VA North Texas Health Care System
Dallas, Texas, United States, 75216
Heart Center of Northe Texas
Fort Worth, Texas, United States, 76104
University of Texas Medical Branch
Galveston, Texas, United States, 77555
United States, Vermont
Fletcher Allen Health Care
Burlington, Vermont, United States, 05401
United States, Washington
Swedish Medical Center
Seattle, Washington, United States, 98122
Allgemeines Krankenhaus AKH
Vienne, Austria, A- 1090
Imelda Ziekenhuis
Bonheiden, Belgium, 2820
AZ Sint-Blasius, Campus Dendermonde
Dendermonde, Belgium, 9200
Ziekenhuis Oost Limburg
Genk, Belgium, 3600
Universitair Ziekenhuis Gent
Gent, Belgium, 9000
Regionaal Ziekenhuis Heilig Hart Tienen
Tienen, Belgium, 3300
Canada, Quebec
Fleurimont Hospital
Sherbrook, Quebec, Canada, J1H 5N4
Guelph General Hospital
Guelph, Canada, N1E 6L9
Hospital Maisonneuve-Rosemont
Montreal, Canada, H1T 2M4
Winnipeg Health Sciences Centre
Winnipeg, Canada, R3A 1R9
Center or Diagnostic Radiology and Minimally Invasive Therapy / Gefäßzentrum am JuedischenKrankenhaus
Berlin, Germany, 13347
Ev. Luth. Diakonissenanstalt Flensburg
Flensburg, Germany, 24939
Herzzentrum Leipzig GmbH/Park Krankenhaus
Leipzig, Germany, 04289
Friedrich-Ebert-Krankenhaus Neumuenster GmbH
Neumuenster, Germany, 24534
Kokura Memorial Hospital
Kitakyushu-shi, Fukuoka, Japan, 802-8055
Tokeidai Memorial Hospital
Sapporo-shi, Hokkaido, Japan, 060-0031
Kansai Rosai Hospital
Amagasaki-shi, Hyogo, Japan, 660-8511
Kishiwada Tokushukai Hospital
Kishiwada-shi, Osaka-fu, Japan, 596-8522
Tokyo Women's Medical University Hospital
Shinjuku-ku, Tokyo, Japan, 162-8666
Morinomiya Hospital
Osaka, Japan, 536-0025
United Kingdom
Northern General Hospital
Sheffield, United Kingdom, S5 7AU
Sponsors and Collaborators
Boston Scientific Corporation
Principal Investigator: Richard J Powell, MD Dartmouth-Hitchcock Medical Center

Responsible Party: Boston Scientific Corporation Identifier: NCT01292928     History of Changes
Other Study ID Numbers: G100291
First Posted: February 10, 2011    Key Record Dates
Results First Posted: January 20, 2016
Last Update Posted: March 8, 2017
Last Verified: January 2017

Keywords provided by Boston Scientific Corporation:
Atherosclerosis, Superficial Femoral Artery (SFA), Proximal Popliteal Artery (PPA), lower extremities, Stenting

Additional relevant MeSH terms:
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases